Senior Medical Devices Assessor/Auditor

19 hours ago


India beBeeRegulatoryAffairs Full time US$ 90,000 - US$ 1,20,000
Job Title: Senior Medical Devices Assessor/Auditor

We are seeking a seasoned professional to join our team as a Senior Medical Devices Assessor/Auditor. This is an exciting opportunity for a highly skilled individual with expertise in medical devices, quality management, and regulatory affairs.

The ideal candidate will have at least 10 years of experience in the relevant field, including 5+ years in quality management. A strong knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR is essential.

  • A solid understanding of risk management principles and practices, particularly EN ISO 14971.
  • Experience with non-active devices and sterilization processes.
  • The ability to work effectively as part of a team, collaborating with assessors and auditors.

This role offers a unique chance to utilize your skills and experience to drive excellence in medical devices assessment and auditing.

Interested candidates can apply or share their updated CV on the specified platform.



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